The Role of Extended Antral Resection on Weight Loss and Metabolic Response After Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin(Hb A1c) (mmol/mol) change
研究概览
简要总结
Aim: The impact of extended antral resection (AR) after laparoscopic sleeve gastrectomy (LSG) on weight loss changes and metabolic response is still not clearly elucidated with conflicting results. The investigator's retrospective cohort study aimed to determine whether AR is superior to antral preservation (AP) regarding weight loss and resolution of co-morbidities.
Methods: Patients were divided into two groups according to the distance of gastric division as AR group (2cm from pylorus) and AP group (6cm from pylorus). Postoperative excess weight loss percentile (%EWL) and total body weight loss percentiles (%TBWL) at the end of first, 6th and 12 months were compared. Secondly, metabolic parameters and complications were compared.
详细描述
Following approval of the ethical committee patients who underwent LSG between January 2016 and June 2018 are retrospectively analyzed. Patients with BMI > 40 were included. Patients with a history of previous bariatric surgery and patients who did not attend regular follow-up visits (first, 6th and 12 months) are excluded.
The patients were grouped according to the distance of gastric division as AP group (6cm from pylorus) and AR group (2cm prom pylorus). The first 68 patients underwent AP, and the following 43 patients underwent AR.
Patient characteristics and demographic data, including age, gender, BMI, co-morbid diseases (hypertension (HT), Type II diabetes, dyslipidemia), biochemical parameters (glucose, HbA1c, C-peptide, insulin, , cholesterol, triglyceride, HDL, LDL, and VLDL was extracted from a prospectively prepared patient's chart. The 30-day outcomes including postoperative morbidity and mortality are taken from patient's folder.
Weight loss alteration at the end of first, 6th and 12 months are calculated as %EWL and %TBWL. The %EWL is calculated as [(preoperative weight - follow up weight) / (preoperative weight-ideal weight)] x100, with ideal weight based on a BMI of 25kg/m2. The total body weight loss percentile (%TBWL) is calculated as [(preoperative weight - follow up weight) / (preoperative body weight)] x100.
Resolution of co-morbidities was defined as reduction of co-morbidity related symptom and signs with change of specific biochemical blood tests to normal ranges.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Body Mass Index > 40 were included
排除标准
- •Patients with a history of previous bariatric surgery and patients who did not attend regular follow-up visits (first, 6th and 12 months) are excluded
结局指标
主要结局
Glycated hemoglobin(Hb A1c) (mmol/mol) change
时间窗: 0, 12. month
Preoperative glycated hemoglobin(Hb A1c) (mmol/mol) values compared with glycated hemoglobin(Hb A1c) (mmol/mol) values at 12 months.
Cholesterol (mg/dl) levels change
时间窗: 0, 12. month
Preoperative Cholesterol (mg/dl) values compared with Cholesterol (mg/dl) values at 12 months.
HDL (mg/dl) levels change
时间窗: 0, 12. month
Preoperative HDL(mg/dl) values compared with HDL(mg/dl) values at 12 months.
VLDL (mg/dl) levels change
时间窗: 0, 12. month
Preoperative VLDL(mg/dl) values compared with VLDL(mg/dl) values at 12 months.
Glucose(mg/dl) change
时间窗: 0, 12. month
Preoperative fasting glucose (mg/dl) values compared with fasting glucose (mg/dl) values at 12 months.
C-Peptide(ng/ml) change
时间窗: 0, 12. month
Preoperative C-peptide (ngl/ml) values compared with C-peptide (ngl/ml) values at 12 months.
Excess Weight Loss change
时间窗: 0,1,6, 12. month
The %Excess Weight Loss is calculated as \[(preoperative weight - follow up(1,6,12 month weight) / (preoperative weight-ideal weight)\] x100, with ideal weight based on a BMI of 25kg/m2.
Insulin (mg/dl) change
时间窗: 0, 12. month
Preoperative Insulin (mg/dl) values compared with Insulin (mg/dl) values at 12 months.
LDL (mg/dl) levels change
时间窗: 0, 12. month
Preoperative LDL(mg/dl) values compared with LDL(mg/dl) values at 12 months.
The total body weight loss percentile change
时间窗: 0,1,6, 12. month
The total body weight loss percentile (%TBWL) is calculated as \[(preoperative weight - follow up(1,6,12. month weight) / (preoperative body weight)\] x100. ideal weight based on a BMI of 25kg/m2
Triglyceride(mg/dl) levels change
时间窗: 0, 12. month
Preoperative Triglyceride(mg/dl) values compared with Triglyceride(mg/dl) values at 12 months.
Resolution of co-morbidities
时间窗: 0,12. month
Resolution of co-morbidities (hypertension, hyperlipidemia, diabetes type 2) was defined as reduction of co-morbidity related symptom and signs with change of specific biochemical blood tests to normal ranges. Preoperative status will be compared with 12.months status.
次要结局
- complication(1 year)
研究者
Adem Yuksel
M.D. Department of Gastroenterological surgery,Principal Investigator
Kocaeli Derince Education and Research Hospital